Clearance Summary
ORION'S URETHRAL CATHETERIZATION KIT WITH CATHETER AND BAG received FDA 510(k) clearance under submission number K944378, sponsored by Regulatory & Marketing Services, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 1995-02-15.
- Submission: K944378
- Applicant / Sponsor: Regulatory & Marketing Services, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.4730
- Decision date: 1995-02-15
Classification & Regulation
This clearance is catalogued under FDA product code FGM and 21 CFR 876.4730, within the Gastroenterology, Urology review panel as a Class I device.